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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 June to 4 July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
On one occasion the temperature was outside the protocol limit of 23'C. This deviation was considered not to affect the purpose or integrity of the study.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Supplied by sponsor
- Date Recieved: 1 June 1995


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
At the start of the study the animals weighed 2.45 to 2.67 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 18 to 24' C and relative humidity of 45 to 59%. The rate of air exchange was approximately 15
changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness. On one occasion the
temperature was outside the protocol limit of 23'C. This deviation was considered not to affect the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/animal
Duration of treatment / exposure:
4 Hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact
epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape
(BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an
elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J.H., (1 977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington D.C. p.31.
SCORING SYSTEM:The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 Days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Mild Irritation
Irritant / corrosive response data:
Very slight to well-defined erythema was noted at all treated skin sites at the 1-hour observation with very slight erythema at the 24-hour observation. Very slight erythema was noted at four treated skin sites at the 48-hour observation and three treated skin sites at the 72-hour observation.
Very slight oedema was noted at all treated skin sites at the 1-hour observation.
Desquamation, which was considered to be reversible so did not warrant continuation of the observation period, was noted at four treated skin sites at the 7-day observation.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritancy potential of the test material was assessed inaccordance with OCED Guideline 404. The test material, produced a primary irritation index of 0.72 in relation to erythema only, and which was fully reversible by the 7-day observation period. Therefore, the test material can be considered to be not irritiating and does not meet the GHS criteria for classification.
Executive summary:

Guideline

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method followed the recommendations of the US Environmental Protection Agency (EPA) Guidelines, OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method 84 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 6 7/548/E EC) and Austrialian Toxicology Guidelines.

Method

A single 4-hour, semi-occluded application of the test material to the intact skin of six rabbits produced very slight to well-defined erythema and very slight oedema. Desquamation was noted on day 7 but was considered to be a reversible effect which did not warrant continuation of the observation period.

Results

The test material, produced a primary irritation index of 0.72 in relation to erythema only, and which was fully reversible by the 7-day observation period.

The substance is not classified for skin irritation in accordance with the CLP Regulation 1272/2008.